Clinical Evaluation Of Remote Monitoring With Direct Alerts To Reduce Time From Event To Clinical Decision (REACT)

Abbott

Status: Completed

Conditions: The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) Device

Treatments: Device: Implantation of an ICD/CRT-D device; Device: Merlin.NET PCN

Study type: Interventional

Funder types: Industry

Identifiers

NCT01090349

CR-09-064-WW-RC

Details and patient eligibility

About

St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment or replace routine scheduled in-clinic visits.

This investigation is designed with the hypothesis that detection of events (system integrity and diagnostic related) through Direct Alerts™ via Remote Monitoring allow clinicians an earlier opportunity to address and resolve events and may therefore improve patient care.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient meets ACC/AHA/ESC guidelines for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-D) device
• The patient is recently (≤2 weeks) implanted with a SJM device compatible with the Merlin.net™ PCN - (inclusive of upgrade from ICD to CRT-D or an implantable pulse generator change)
• The patient has a life expectancy of greater than 12 months (based on the physician's discretion).
• The patient is mentally capable to participate in the investigation (based on the physician's discretion).
• The patient is 18 years of age or older

Exclusion criteria

• The patient is being actively considered for cardiac transplantation.
• The patient has primary valvular disease that has not been corrected.
• The patient had a myocardial infarction within the last month
• The patient had unstable angina within the last month.
• The patient has had Coronary Artery Bypass Grafting (CABG) within the last month.
• The patient had a Percutaneous Coronary Angioplasty (PTCA) within the last month.
• The patient is pregnant.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Direct Alerts ON

Experimental group

Description:

Direct Alerts in implantable device were turned on

Treatment:

Device: Merlin.NET PCN

Device: Implantation of an ICD/CRT-D device

Direct Alerts OFF

Active Comparator group

Description:

Direct Alerts in implantable device were turned off

Treatment:

Device: Merlin.NET PCN

Device: Implantation of an ICD/CRT-D device